HIPEC during Surgery for Ovarian Cancer

(HIPEC Trial)

Overseen By Study Nurse

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Wake Forest University Health Sciences

Must be taking: Platinum chemotherapy

Disqualifiers: Radiation, Adhesive disease, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the potential benefits of using heated chemotherapy, known as HIPEC, during follow-up surgery for ovarian cancer. The researchers aim to determine if delivering chemotherapy directly into the abdomen during surgery can improve patient outcomes. Individuals who have had ovarian, fallopian tube, or peritoneal cancer, completed initial treatments, and show no current signs of disease may qualify. Participants will undergo a laparoscopic procedure, called second look laparoscopy reassessment surgery (SLLRS), to evaluate their condition before receiving the heated chemotherapy. The trial seeks to assess the effectiveness and safety of this approach. As a Phase 2 trial, the research focuses on measuring the treatment's efficacy in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it does require that you have completed a specific course of platinum-based chemotherapy before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that carboplatin, when used in HIPEC (a treatment where heated chemotherapy is applied directly into the abdomen), is generally well-tolerated. One study found carboplatin to be both effective and safe in this setting. Most side effects were mild, particularly at a specific dose, and mainly involved manageable changes in blood cell counts.

Combining surgery with HIPEC has also shown promise for treating ovarian cancer. This combination may improve patient outcomes without adding significant risks. Overall, evidence suggests that using carboplatin with HIPEC could be a safe option for those considering this type of treatment trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for ovarian cancer, which typically involve intravenous chemotherapy, the study treatment combines Second Look Laparoscopy Reassessment Surgery (SLLRS) with Hyperthermic Intraperitoneal Chemotherapy (HIPEC) using carboplatin. This approach is unique because it delivers heated chemotherapy directly into the abdominal cavity, allowing for higher local concentrations of the drug with potentially fewer systemic side effects. Researchers are excited about this method because it targets residual cancer cells more effectively right after surgical tumor removal, offering hope for improved outcomes in patients with minimal residual disease.

What evidence suggests that HIPEC during surgery could be effective for ovarian cancer?

Research has shown that HIPEC, a treatment involving heated chemotherapy with carboplatin, may be effective for ovarian cancer. In this trial, participants will undergo Second Look Laparoscopy and HIPEC with Carboplatin. One study found that adding HIPEC to surgery and regular chemotherapy significantly improved survival rates over five years and increased the time patients remained cancer-free. Another study observed that HIPEC with carboplatin boosts the immune system and activates certain genes that help protect cells. For patients with remaining ovarian cancer after initial treatment, those who received HIPEC lived longer on average than those who did not. While results on delaying cancer progression are mixed, HIPEC has proven safe and practical for repeated use. ^{6 7 8 9 10}

Who Is on the Research Team?

Laurel Berry, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 with specific types of ovarian, fallopian tube, or peritoneal cancer. Participants must have completed certain surgeries and chemotherapy within a set timeframe, have no current evidence of disease, and meet specific health criteria like organ function. Pregnant individuals or those with recent infections, severe allergies to carboplatin, or unstable health conditions are excluded.

Inclusion Criteria

Ability to understand and the willingness to sign an IRB-approved informed consent document

I show no signs of cancer after chemotherapy, confirmed by exams and tests.

My surgery removed all visible cancer before starting chemotherapy.

Exclusion Criteria

You have had allergic reactions to drugs similar to carboplatin.

Pregnancy

I have not had radiation therapy to my abdomen or pelvis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo second look laparoscopy and may receive hyperthermic intraperitoneal chemotherapy (HIPEC) with carboplatin if visible signs of cancer are present.

Up to 3 months

Follow-up

Participants are monitored for quality of life and toxicities using the FACT-O questionnaire and CTCAE criteria.

Up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Second look laparoscopy reassessment surgery (SLLRS)

Trial Overview

The study tests the feasibility and impact on quality of life when administering heated chemotherapy (HIPEC) during a second look laparoscopy surgery in patients who've had prior treatment for certain cancers. The FACT-O questionnaire will assess participants' quality of life outcomes.

How Is the Trial Designed?

Group I: Second Look Laparoscopy and HIPEC with Carboplatin Experimental Treatment 3 Interventions

Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 122 patients undergoing 124 cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CS-HIPEC) procedures, the in-hospital mortality rate was nearly zero, and the 30-day mortality rate was only 1.6%, indicating a significant improvement in safety for this treatment approach.

Despite the low mortality rates, the study reported a high overall morbidity rate of 56.5%, with major complications occurring in 29.8% of cases, highlighting the need for further research to optimize patient outcomes in the treatment of peritoneal carcinomatosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aggressive surgical management of peritoneal carcinomatosis with low mortality in a high-volume tertiary cancer center. Gusani, NJ., Cho, SW., Colovos, C., et al.[2022]

In a multicenter phase-I study involving 30 patients with initially unresectable ovarian cancer, the recommended dose of cisplatin for hyperthermic intraperitoneal chemotherapy (HIPEC) after neoadjuvant chemotherapy was determined to be 70 mg/m², as higher doses led to significant dose-limiting toxicities (DLTs).

The study found that at the highest dose of 80 mg/m², there were serious adverse events including renal failure and hemorrhage, highlighting the importance of careful dose selection to minimize toxicity while maximizing treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a multicenter phase I dose-finding trial of hyperthermic intraperitoneal cisplatin after neoadjuvant chemotherapy and complete cytoreductive surgery and followed by maintenance bevacizumab in initially unresectable ovarian cancer. Gouy, S., Ferron, G., Glehen, O., et al.[2022]

In a study of 15 patients with peritoneal carcinomatosis, the combination of cytoreductive surgery (CS) followed by intraperitoneal hyperthermic chemotherapy (IPHC) resulted in a median survival time of 8.4 months, which aligns with previous research findings.

The treatment was associated with significant surgical interventions, including bowel resections and blood transfusions, indicating a complex perioperative course, and highlights the need for further research to explore factors influencing survival and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytoreductive surgery and intraperitoneal hyperthermic chemotherapy in the treatment of peritoneal carcinomatosis. Gammon, DC., Dutton, T., Piperdi, B., et al.[2019]

Cytoreductive surgery combined with intraperitoneal hyperthermic chemoperfusion (IHCP) shows a high risk of postoperative complications (44.3%), but with proper patient selection and care, most complications can be managed effectively.

Completeness of cancer resection and patient age are significant predictors of postoperative morbidity, highlighting the importance of thorough surgical techniques and careful patient assessment in improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of peritoneal carcinomatosis by cytoreductive surgery and intraperitoneal hyperthermic chemoperfusion (IHCP): postoperative outcome and risk factors for morbidity. Roviello, F., Marrelli, D., Neri, A., et al.[2022]

In a study of 33 patients undergoing cytoreductive surgery and intraperitoneal hyperthermic chemoperfusion (IPHC), complete removal of cancer was achieved in 63% of cases, indicating the treatment's potential efficacy for peritoneal malignancies.

The procedure was associated with a 27% rate of major complications but no perioperative deaths, suggesting that with careful surgical techniques, the risks can be managed effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced morbidity following cytoreductive surgery and intraperitoneal hyperthermic chemoperfusion. Ahmad, SA., Kim, J., Sussman, JJ., et al.[2007]

In a study of 25 patients with advanced-stage ovarian cancer, cytoreductive surgery combined with carboplatin HIPEC showed no deaths or severe adverse events (grade 4-5), indicating a favorable safety profile.

While 44% of patients experienced at least one grade 3 adverse event, primarily infections and neutropenia, the overall morbidity was considered acceptable, supporting the feasibility of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morbidity after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with carboplatin used for ovarian, tubal, and primary peritoneal cancer. Mikkelsen, MS., Christiansen, T., Petersen, LK., et al.[2019]

In a study of 205 patients undergoing cytoreductive surgery (CRS) and intraperitoneal hyperthermic perfusion (IPHP) for peritoneal surface malignancies, the major morbidity rate was 12%, with an operative mortality rate of only 0.9%, indicating that the procedure is relatively safe.

The study identified that the extent of cytoreduction and a higher dose of cisplatin (≥240 mg) during IPHP were significant risk factors for major complications, suggesting that careful management of these factors is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytoreductive surgery followed by intraperitoneal hyperthermic perfusion: analysis of morbidity and mortality in 209 peritoneal surface malignancies treated with closed abdomen technique. Kusamura, S., Younan, R., Baratti, D., et al.[2022]

In a study of 32 patients undergoing hyperthermic intraperitoneal chemotherapy (HIPEC) during cytoreductive surgery (CRS) for endometrial and epithelial ovarian cancer, the procedure showed a low operative mortality rate of 3% and a severe morbidity rate of 12%, indicating it is relatively safe.

Among the 30 patients with epithelial ovarian cancer, the 1-year overall survival rate was 69.7%, and for the platinum-resistant subgroup, the median overall survival was 14 months, suggesting that HIPEC can provide promising short-term outcomes even in challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Retrospective Clinical Analysis of Hyperthermic Intraperitoneal Chemotherapy in Gynecological Cancers: Technical Details, Tolerability, and Efficacy. Minareci, Y., Tosun, OA., Sozen, H., et al.[2022]

In a phase II study involving 98 patients with recurrent ovarian cancer, hyperthermic intraperitoneal chemotherapy (HIPEC) using carboplatin was found to be well tolerated, with no perioperative mortality and similar postoperative toxicity compared to standard treatment.

However, HIPEC did not demonstrate superior clinical outcomes, as the median progression-free survival was shorter in the HIPEC group (12.3 months) compared to the standard treatment group (15.7 months), leading to the conclusion that HIPEC with carboplatin is not recommended during secondary cytoreductive surgery for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary Cytoreduction and Carboplatin Hyperthermic Intraperitoneal Chemotherapy for Platinum-Sensitive Recurrent Ovarian Cancer: An MSK Team Ovary Phase II Study. Zivanovic, O., Chi, DS., Zhou, Q., et al.[2023]

The maximum tolerated dose (MTD) of carboplatin for intraperitoneal hyperthermic chemotherapy (IPHC) was established at 1000 mg/m², as higher doses led to significant toxicity.

Patients who received IPHC at the MTD were able to complete standard systemic chemotherapy afterward, and repeat IPHC was safely performed during second look surgeries without severe toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraperitoneal hyperthermic chemotherapy using carboplatin: a phase I analysis in ovarian carcinoma. Lentz, SS., Miller, BE., Kucera, GL., et al.[2013]

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